The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Codman Craniosorb Absorbable Fixation System Drill Bits.
Device ID | K002798 |
510k Number | K002798 |
Device Name: | CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS |
Classification | Plate, Bone |
Applicant | Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Contact | James M Flaherty |
Correspondent | James M Flaherty Codman & Shurtleff, Inc. 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-09-07 |
Decision Date | 2000-12-06 |